Food and Drug Administration
Oncologic Drugs Advisory Committee
December 6, 2001
Briefing Information
Morning Session
NDA 20-571, Camptosar® Injection (irinotecan hydrochloride injection), Pharmacia & Upjohn Company, combined with 5FU/leucovorin ("Saltz" regimen), approved for the first-line treatment of patients with metastatic colorectal cancer: Post-marketing safety issues
Sponsor Information
Disclaimer
The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.
Pharmacia & Upjohn Company [pdf version]
Pharmacia & Upjohn Company, errata page [pdf version]
Food and Drug Administration Information
Executive Summary [pdf version] [htm version] [Word version]
Camptosar + 5-FU/LV for First-Line Treatment of Metastatic Colorectal Cancer: Post-Marketing Reevaluation of Safety, November 2001, Isagani M Chico, MD [pdf version] [htm version] [Word version]